Description
Vaccinia immune globulin is used to treat infections caused by the vaccinia virus.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Studies on this medicine have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin in children with use in other age groups.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaccinia immune globulin in the elderly with use in other age groups.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Dengue Tetravalent Vaccine, Live
- Influenza Virus Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Poliovirus Vaccine, Live
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- Zoster Vaccine, Live
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Vaccinia keratitis—Use is not recommended.
- Hyperviscosity, known or suspected—May increase chance for serious side effects
- Immunoglobulin A (IgA) deficiency—Increased risk for allergic reaction
Proper Use
Make sure you discuss the risks and benefits of this medicine with your doctor.
Report all infections thought to have been possibly transmitted by this product by having your doctor call Cangene Corporation at 1-877-CANGENE.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For injectable dosage form:
- For treatment and/or medical problems due to vaccinia virus:
- Adults—Dose is based on weight and will be determined by your doctor.
- Children—Use and dose must be determined by your doctor.
- For treatment and/or medical problems due to vaccinia virus:
Precautions
Tell your healthcare provider if you have ever had a reaction to a vaccination.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence unknown
- Fever
- headache
- nausea
- stiff neck or back
Observed postmarketing
- Back, leg or stomach pain
- black, tarry stools
- bleeding gums
- blistering, peeling, loosening of skin
- bluish color of fingernails, lips, skin, palms, or nail beds
- blurred vision
- change in consciousness
- chest pain
- chills
- cold, clammy, pale skin
- confusion
- convulsions
- cough
- coughing that produces a pink frothy sputum
- dark urine
- decreased urination
- diarrhea
- difficulty or labored breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- fatigue
- general body swelling
- itching
- irregular heartbeats
- joint or muscle pain
- light-colored stools
- loss of appetite
- loss of bladder control
- loss of consciousness
- muscle spasms or jerking of all extremities
- nausea or vomiting
- no blood pressure or pulse
- noisy breathing
- nosebleeds
- not breathing
- pain in chest, groin, or legs, especially the calves
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- severe, sudden headache
- severe weakness or numbness in arm or leg
- shortness of breath
- slow heart rate
- slurred speech
- sore throat
- sores, ulcers, or white spots in mouth or on lips
- stopping of heart
- sudden loss of coordination
- suddenly sweating
- swelling in legs and ankles
- swollen glands
- tightness in chest
- troubled breathing
- unconsciousness
- unusual bleeding or bruising
- unusual tiredness or weakness
- vision changes
- wheezing
- yellowing of the eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- eye disorder
- energy increased
- feeling unusually cold
- feeling hot
- lack or loss of strength
- lip dry
- muscle pain
- shakiness in legs, arms, hands, feet
- shivering
- trembling or shaking of hands or feet
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20067348
